BILL NUMBER: SB 1364	CHAPTERED  09/30/00

	CHAPTER   941
	FILED WITH SECRETARY OF STATE   SEPTEMBER 30, 2000
	APPROVED BY GOVERNOR   SEPTEMBER 29, 2000
	PASSED THE SENATE   AUGUST 28, 2000
	PASSED THE ASSEMBLY   AUGUST 21, 2000
	AMENDED IN ASSEMBLY   JULY 3, 2000
	AMENDED IN ASSEMBLY   JUNE 7, 2000

INTRODUCED BY   Senator Johnston

                        JANUARY 19, 2000

   An act to amend Section 56.17 of the Civil Code, and to amend
Section 124980 of, to amend and renumber Section 125005 of, and to
add Section 124981 to, the Health and Safety Code, relating to
health, and making an appropriation therefor.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1364, Johnston.  Genetics:  test disclosure.
   Existing law, the Confidentiality of Medical Information Act,
imposes prohibitions on the disclosure of the results of a test for a
genetic characteristic contained in an applicant's or enrollee's
medical records by a health care service plan.
   This bill would specify, for those prohibitions, a definition for
the term "genetic characteristic," that is the same as the definition
contained in existing provisions regarding health care service
plans.
   Existing law requires the State Department of Health Services to
recommend appropriate criteria and standards for licensing genetic
counselors, and requires the department to consult with a group of
medical experts representing medical professional organizations
during the process of developing and recommending the criteria and
standards.
   This bill, instead, would require that standards for hereditary
disorders programs established by the department include licensure of
master level genetic counselors and doctoral level clinical
geneticists.  The bill would also require that counseling services
for hereditary disorders be provided by a physician or other
appropriately trained licensed health care professional.
   The bill would prohibit any person from using the title of genetic
counselor unless the person has applied for and obtained a license
from the department.  The bill would specify licensing requirements
with regard to a genetic counselor.
   Existing law authorizes the department to charge a fee for genetic
disease testing of children and requires that all moneys collected
be deposited in the Genetic Disease Testing Fund, a continuously
appropriated special fund.
   This bill would authorize the department to charge fees for
licensing activities required under the bill and would require the
fees collected to be deposited in the Genetic Disease Testing Fund.
Because this bill would provide for new fees to be deposited into the
Genetic Disease Testing Fund, a continuously appropriated special
fund, this bill would make an appropriation.
   Appropriation:  yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 56.17 of the Civil Code is amended to read:
   56.17.  (a) This section shall apply to the disclosure of genetic
test results contained in an applicant's or enrollee's medical
records by a health care service plan.
   (b) Any person who negligently discloses results of a test for a
genetic characteristic to any third party in a manner that identifies
or provides identifying characteristics of the person to whom the
test results apply, except pursuant to a written authorization as
described in subdivision (g), shall be assessed a civil penalty in an
amount not to exceed one thousand dollars ($1,000) plus court costs,
as determined by the court, which penalty and costs shall be paid to
the subject of the test.
   (c) Any person who willfully discloses the results of a test for a
genetic characteristic to any third party in a manner that
identifies or provides identifying characteristics of the person to
whom the test results apply, except pursuant to a written
authorization as described in subdivision (g), shall be assessed a
civil penalty in an amount not less than one thousand dollars
($1,000) and no more than five thousand dollars ($5,000) plus court
costs, as determined by the court, which penalty and costs shall be
paid to the subject of the test.
   (d) Any person who willfully or negligently discloses the results
of a test for a genetic characteristic to a third party in a manner
that identifies or provides identifying characteristics of the person
to whom the test results apply, except pursuant to a written
authorization as described in subdivision (g), that results in
economic, bodily, or emotional harm to the subject of the test, is
guilty of a misdemeanor punishable by a fine not to exceed ten
thousand dollars ($10,000).
   (e) In addition to the penalties listed in subdivisions (b) and
(c), any person who commits any act described in subdivision (b) or
(c) shall be liable to the subject for all actual damages, including
damages for economic, bodily, or emotional harm which is proximately
caused by the act.
   (f) Each disclosure made in violation of this section is a
separate and actionable offense.
   (g) The applicant's "written authorization," as used in this
section, shall satisfy the following requirements:
   (1) Is written in plain language.
   (2) Is dated and signed by the individual or a person authorized
to act on behalf of the individual.
   (3) Specifies the types of persons authorized to disclose
information about the individual.
   (4) Specifies the nature of the information authorized to be
disclosed.
   (5) States the name or functions of the persons or entities
authorized to receive the information.
   (6) Specifies the purposes for which the information is collected.

   (7) Specifies the length of time the authorization shall remain
valid.
   (8) Advises the person signing the authorization of the right to
receive a copy of the authorization.  Written authorization is
required for each separate disclosure of the test results.
   (h) This section shall not apply to disclosures required by the
Department of Health Services necessary to monitor compliance with
Chapter 1 (commencing with Section 124975) of Part 5 of Division 106
of the Health and Safety Code, nor to disclosures required by the
Department of Managed Care necessary to administer and enforce
compliance with Section 1374.7 of the Health and Safety Code.
   (i) For purposes of this section, "genetic characteristic" has the
same meaning as that set forth in subdivision (d) of Section 1374.7
of the Health and Safety Code.
  SEC. 2.  Section 124980 of the Health and Safety Code is amended to
read:
   124980.  The director shall establish any regulations and
standards for hereditary disorders programs as the director deems
necessary to promote and protect the public health and  safety.
Standards shall include licensure of master level genetic counselors
and doctoral level clinical geneticists.  Regulations adopted shall
implement the principles established in this section.  These
principles shall include, but not be limited to, the following:
   (a) The public, especially communities and groups particularly
affected by programs on hereditary disorders, should be consulted
before any regulations and standards are adopted by the department.
   (b) The incidence, severity, and treatment costs of each
hereditary disorder and its perceived burden by the affected
community should be considered and, where appropriate, state and
national experts in the medical, psychological, ethical, social, and
economic effects or programs for the detection and management of
hereditary disorders shall be consulted by the department.
   (c) Information on the operation of all programs on hereditary
disorders within the state, except for confidential information
obtained from participants in the programs, shall be open and freely
available to the public.
   (d) Clinical testing procedures established for use in programs,
facilities, and projects shall be accurate, provide maximum
information, and the testing procedures selected shall produce
results that are subject to minimum misinterpretation.
   (e) No test or tests may be performed on any minor over the
objection of the minor's parents or guardian, nor may any tests be
performed unless the parent or guardian is fully informed of the
purposes of testing for hereditary disorders and is given reasonable
opportunity to object to the testing.
   (f) No testing, except initial screening for phenylketonuria (PKU)
and other diseases that may be added to the newborn screening
program, shall require mandatory participation, and no testing
programs shall require restriction of childbearing, and participation
in a testing program shall not be a prerequisite to eligibility for,
or receipt of, any other service or assistance from, or to
participate in, any other program, except where necessary to
determine eligibility for further programs of diagnoses of or therapy
for hereditary conditions.
   (g) Pretest and posttest counseling services for hereditary
disorders shall be available through the program or a referral source
for all persons determined to be or who believe themselves to be at
risk for a hereditary disorder.  Genetic counseling shall be provided
by a physician, a certified advanced practice nurse with a genetics
specialty, or other appropriately trained licensed health care
professional and shall be nondirective, shall emphasize informing the
client, and shall not require restriction of childbearing.
   (h) All participants in programs on hereditary disorders shall be
protected from undue physical and mental harm, and except for initial
screening for phenylketonuria (PKU) and other diseases that may be
added to newborn screening programs, shall be informed of the nature
of risks involved in participation in the programs, and those
determined to be affected with genetic disease shall be informed of
the nature, and where possible the cost, of available therapies or
maintenance programs, and shall be informed of the possible benefits
and risks associated with these therapies and programs.
   (i) All testing results and personal information generated from
hereditary disorders programs shall be made available to an
individual over 18 years of age, or to the individual's parent or
guardian.  If the individual is a minor or incompetent, all testing
results that have positively determined the individual to either
have, or be a carrier of, a hereditary disorder shall be given
through a physician or other source of health care.
   (j) All testing results and personal information from hereditary
disorders programs obtained from any individual, or from specimens
from any individual, shall be held confidential and be considered a
confidential medical record except for information that the
individual, parent, or guardian consents to be released, provided
that the individual is first fully informed of the scope of the
information requested to be released, of all of the risks, benefits,
and purposes for the release, and of the identity of those to whom
the information will be released or made available, except for data
compiled without reference to the identity of any individual, and
except for research purposes, provided that pursuant to Subpart A
(commencing with Section 46.101) of Part 46 of Title 45 of the Code
of Federal Regulations entitled "Basic HHS Policy for Protection of
Human Subjects," the research has first been reviewed and approved by
an institutional review board that certifies the approval to the
custodian of the information and further certifies that in its
judgment the information is of such potentially substantial public
health value that modification of the requirement for legally
effective prior informed consent of the individual is ethically
justifiable.
   (k) An individual whose confidentiality has been breached as a
result of any violation of the provisions of the Hereditary Disorders
Act, as defined in subdivision (b) of Section 27, may recover
compensatory damages and, in addition, may recover civil damages not
to exceed ten thousand dollars ($10,000), reasonable attorney's fees,
and the costs of litigation.
   (l) "Genetic counseling" as used in this section shall not include
communications that occur between patients and appropriately trained
and competent licensed health care professionals, such as
physicians, registered nurses, and physicians assistants who are
operating within the scope of their license and qualifications as
defined by their licensing authority.
  SEC. 3.  Section 124981 is added to the Health and Safety Code, to
read:
   124981.  (a) No person shall use the title of genetic counselor
unless the person has applied for and obtained a license from the
department.
   (b) The applicant for a genetic counselor license shall meet
minimum qualifications that include but are not limited to all of the
following:
   (1) Has earned a master's degree or above from a program
specializing in or having substantial course content in genetics.
   (2) Has demonstrated competence by an examination administered or
approved by the department.
   (c) The license shall be valid for three years unless at any time
during that period it is revoked or suspended.  The license may be
renewed prior to the expiration of the three-year period.
   (d) To qualify to renew the license, a licenseholder shall have
completed 45 hours of continuing education units during the
three-year license renewal period.  At least 30 hours of the
continuing education units shall be in genetics.
   (e) The license fee for an original license and license renewal
shall not exceed two hundred dollars ($200).
  SEC. 4.  Section 125005 of the Health and Safety Code is amended
and renumbered to read:
   124996.  (a) The Genetic Disease Testing Fund is continued in
existence as a special fund in the State Treasury.  The department
may charge a fee for any activities carried out pursuant to the
Hereditary Disorders Act, including licensing activities conducted
pursuant to Section 124980.  All moneys collected by the department
under the act shall be deposited in the Genetic Disease Testing Fund,
that is continuously appropriated to the department to carry out the
purposes of the act.
   (b) It is the intent of the Legislature that the program carried
out pursuant to the act be fully supported from fees collected under
the act.
   (c) The director shall adopt regulations establishing the amount
of fees for activities carried out pursuant to the act.
   (d) The "Hereditary Disorders Act" or "act" referred to in this
section is the act described in subdivision (b) of Section 27.
